Manager, Quality System - Continuous Improvement

Job Description

Manager, Quality System - Continuous Improvement Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers. Novocure Poland is our newest office in Europe and you will be part of a global business services team supporting multiple business functions including finance and payroll and located in Krakow. The global business services organization within Novocure Poland is critical to Novocure’s efforts to drive process efficiency, standardizations and drive greater business value as the company prepares for future growth. Your responsibilities: Manage and develop the team required to drive continuous improvement to support company objectives in compliance with relevant standards and regulations. Manage continuous improvement initiatives to increase compliance and support company objectives. Govern Risk Management activities related to process risk management and corresponding pFMEAs. Analyze process-, product-, test-, and quality management system data in terms of risk and improvement opportunities. Provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as Medical Device Regulation, ISO 13485, FDA 21CFR, MDSAP requirements and other applicable standards. Write quality plans and ensure compliance with quality requirements for projects related to process changes and improvements, as well as projects related to new indications and markets. Act as a contact for quality-related questions in the context of audits by notified bodies and authorities. Participate in internal audits and support the follow-up of internal and external audit findings and recommendations. Support the handling of issues and CAPAs. Participate in the further development of the quality management system according to all applicable standards, regulations and law. Your profile: • University degree in a scientific discipline or related field• Training evidence for Quality Management System Standards and Regulations• Training evidence for auditing (preferred)• At least 5 years of experience in the medical device or pharmaceutical field in a similar or senior level position• Excellent knowledge and experience in terms of regulations, norms and standards in the pharmaceutical or medical device field.• Proficient in LEAN methodologies, change management, and continuous improvement skills.• Knowledge of ISO 13485, FDA 21 CFR, MDR standards for Medical Devices and MDSAP.• Fluent in English, both written and spoken. We are looking forward to receiving your application to Natalia Munchow, Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website or by consulting our patient testimonial videos. #J-18808-Ljbffr